跳至主要内容
临床试验/CTRI/2024/10/075119
CTRI/2024/10/075119尚未招募不适用

The role of preoperative factors, surgical approach, preoperative and postoperative mobilisation for improved surgical outcomes after open elbow arthrolysis in posttraumatic elbow stiffness

Kasturba Medical College Manipal, MAHE1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年10月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
To determine the functional outcome following open elbow arthrolysis

研究概览

简要总结

An observational ambispective cohort study will conducted in a tertiary care center in south India. Patients who underwent elbow arthrolysis for post-traumatic elbow stiffness between 2013 and 2023 will be retrospectively identified and invited to participate. Once the study population is defined, the cohort of patients will be prospectively followed up at the clinic to assess pain, neurological status, stability, range of movements, and functional and radiological outcomes. Patients presenting with posttraumatic stiffness were placed in a structured preoperative therapy program and splinting. Those persisting with moderate to severe types of stiffness three to six months following the therapy program underwent open elbow arthrolysis. The advantages of the medial approach will be identified.

Study hypotheses: Elbow stiffness in patients undergoing the therapy protocol improves and downgrades their stages of stiffness. Functional outcomes improve in patients undergoing open elbow arthrolysis. The medial approach for elbow arthrolysis will show better outcomes. Several preoperative factors like time from injury, severity of stiffness, extrinsic type of stiffness, absence of preoperative heterotopic ossification, and arthritic changes show improved outcomes and can be identified as prognostic factors.

研究设计

研究类型
Observational

入排标准

年龄范围
10.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients of posttraumatic elbow stiffness who had failed trials of a structured post-injury or preoperative therapy program aided with splinting for at least three to six months, had elbow arc of motion of less than 100 degree, flexion less than 105 degree, or extension less than 40 degree at the end of the therapy program and had a minimum of 12 months postoperative followup.

排除标准

  • Patients with moderate stiffness downgraded with post-injury therapy, as well as those with ipsilateral brachial plexus injury and other ipsilateral arm and forearm injuries.

结局指标

主要结局

To determine the functional outcome following open elbow arthrolysis

时间窗: At minimum of 12 months after surgery

次要结局

  • To outline the post-injury or pre- and postoperative mobilization protocol implemented(After therapy protocol)
  • To describe the role of the medial approach(At minimum of 12 months after surgery)
  • To identify various preoperative factors contributing towards favorable functional outcomes in post-traumatic elbow stiffness treated by open elbow arthrosis(At minimum of 12 months after surgery)

研究者

发起方
Kasturba Medical College Manipal, MAHE
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anil K Bhat

Kasturba Medical College Manipal, MAHE

研究点 (1)

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